The study-objective of this prospective randomised dubbelblind clinical trial is to demonstrate superior anaesthesia with infiltration of the portals with 20cc of bupivacaine compared tot not giving portal anaesthesia.
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
pain score at 3 hours post-operative
Secondary outcome
pain score 1, 6, 24 hours post-operative.
satisfaction 24 hours postoperative
adjuvant consuption and time to first dose of adjuvant analgesics.
Background summary
Knee-arthroscopy is performed in day-care surgery. good post-operative
analgesia is therefore important. for optimal analgesia oral and sometimes
direct post-operative intravenous meidcation is used. To raise patientcomfort
and decrease consumption of these adjuvant analgesics, adjuvant local portal
anaesthesia could be beneficial.
Study objective
The study-objective of this prospective randomised dubbelblind clinical trial
is to demonstrate superior anaesthesia with infiltration of the portals with
20cc of bupivacaine compared tot not giving portal anaesthesia.
Study design
Prospective randomised controlled double blind trial
Intervention
portal anaesthesia with 10 cc of bupivacaine 0.5% per portal.
Study burden and risks
for most patients ther is no more risk compared to not participating in the
study because some surgeons already use portal anaesthesia.
For patients of doctors not using portal anaesthesia, the risk is an allergic
reaction to bupivavaine. to our knowledge these reactions are seldom which
should mean between 1:1000 and 1:10.000.
Meibergdreef 9
1105AZ Amsterdam
NL
Meibergdreef 9
1105AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Patients:
undergoing arthroscopy of the knee under general anaesthesia.
age 18-75 years.
ASA Classification I or II.
signed informed consent
Exclusion criteria
Arthoscopig ligament reconstructions.
concurrent participation in other trials.
physical or mental handicaps limiting revalidation or understanding of the trial.
known intolerance for Bupivacaine
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-003410-16-NL |
| CCMO | NL35270.018.11 |